Berodual® Respimat® vs Metered Dose Inhaler in Patients With Chronic Obstructive Pulmonary Disease

NCT ID: NCT02176187

Last Updated: 2014-07-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-04-30

Brief Summary

Study to compare the effect of 'natural' as opposed to 'optimal' technique on the percentage of the dose received from the Respimat® inhaler and metered dose inhaler

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

natural technique, without instructions

randomised sequence of Berodual® Respimat® and Berodual® MDI

Group Type: EXPERIMENTAL

Berodual® Respimat® inhaler

Intervention Type: DRUG

fenoterol hydrobromide 50μg + ipratropium bromide 20μg

Berodual® metered dose inhaler

Intervention Type: DRUG

fenoterol hydrobromide 50μg + ipratropium bromide 20μg

optimal technique, with instructions

randomised sequence of Berodual® Respimat® and Berodual® MDI

Group Type: EXPERIMENTAL

Berodual® Respimat® inhaler

Intervention Type: DRUG

fenoterol hydrobromide 50μg + ipratropium bromide 20μg

Berodual® metered dose inhaler

Intervention Type: DRUG

fenoterol hydrobromide 50μg + ipratropium bromide 20μg

Interventions

Berodual® Respimat® inhaler

fenoterol hydrobromide 50μg + ipratropium bromide 20μg

Intervention Type: DRUG

Berodual® metered dose inhaler

fenoterol hydrobromide 50μg + ipratropium bromide 20μg

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• All patients must have a diagnosis of COPD and must meet the following spirometric criteria:

• Patients must have relatively stable, mild to severe airway obstruction with an forced expiratory volulme in one second (FEV1) ≤70% of predicted normal and FEV1 ≤70% of forced vital capacity (FVC). Predicted normal values calculated according to evolutionary conserved chromosome segments (ECCS)
• Patients who have frequent exacerbations which could be expected to interfere with the patient's ability to participate in the study should be excluded
• Male or non-pregnant/non-lactating female patients aged ≥18 years
• Patients must demonstrate poor MDI technique prior to the start of the study. Presence of any of the following will be considered poor technique:

• Failure to co-ordinate "firing" of an MDI with inhalation
• Too fast an inhalation rate (> 30 litres/minute (L/min))
• Presence of "Cold Freon" effect (MDI spray hitting the back of the throat that caused the patient to stop inhaling)
• All patients must sign an informed consent form prior to participation in the study, i.e. prior to pre-study washout of their usual pulmonary medications
• Current or ex-smokers with a smoking history of >10 pack years

Exclusion Criteria

• Patients with significant diseases other than COPD will be excluded. A significant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study
• Patients with clinically relevant abnormal baseline haematology, blood chemistry or urinalysis, if the abnormality defines a disease listed as an exclusion criterion will be excluded
• Patients with a recent history (i.e. six months or less) of myocardial infarction
• Patients with any unstable or life-threatening cardiac arrhythmia or who have been hospitalised for heart failure within the past year
• Patients who regularly use daytime oxygen therapy for more than 1 hour per day and in the investigator's opinion will be unable to abstain from the use of oxygen
• Patients with known active tuberculosis
• Patients with a history of cancer within the last five years. Patients with treated basal cell carcinoma are allowed
• Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or bronchiectasis
• Patients who have undergone thoracotomy with pulmonary resection. Patients with a history of thoracotomy for other reasons should be evaluated as per exclusion 1
• Patients with any upper respiratory infection in the past 14 days prior to the screening visit or during the baseline period
• Patients who are currently in a pulmonary rehabilitation programme or who have completed a pulmonary rehabilitation programme in the six weeks prior to the screening visit
• Patients with known hypersensitivity to β2-agonists, anticholinergic drugs or any excipients of the active or placebo Berodual®
• Patients with known narrow-angle glaucoma
• Patients who are being treated with antihistamines (H1 receptor antagonists)
• Patients using oral corticosteroid medication at unstable doses (i.e. less than six weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisolone per day or 20 mg every other day
• Patients who are being treated with monamine oxidase inhibitors or tricyclic antidepressants
• Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (i.e. oral or injectable eg Depo-Provera or Noristerat contraceptives, intrauterine devices, diaphragm (plus spermicide) or subdermal implants eg: Norplant®)
• Patients with, in the opinion of the investigator, a history of and/or active significant alcohol or drug abuse
• Patients who have taken an investigational drug within four months or six half lives (whichever is the greater) prior to screening visit and/or the administration of radiolabelled dosage forms within the three months prior to the screening visit
• Radiation exposure from clinical studies, including that from the present study and diagnostic X-rays but excluding background radiation, exceeding 5 millisievert (mSv) in the last 12 months or 10 mSv in the last five years. No patient whose occupational exposure is monitored will participate in the study

Precautions: As with other anticholinergic drugs, Berodual® should be used with caution in patients with prostatic hyperplasia or bladder neck obstruction.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

215.1360

Identifier Type: -

Identifier Source: org_study_id